Clinical Trials (PDQ®)

Pilot Study of Metabolic Biomarkers in Patients With Lung Cancer, Participants at High Risk for Developing Lung Cancer, or Healthy Volunteers. Note: The information about this trial has not been updated by the
sponsor/principal investigator/lead organization. Cancer.gov cannot
verify the accuracy of the information.

Biomarkers for Early Detection of Lung Cancer in Patients With Lung Cancer, Participants at High-Risk for Developing Lung Cancer, or Healthy Volunteers. Note: The information about this trial has not been updated by the
sponsor/principal investigator/lead organization. Cancer.gov cannot
verify the accuracy of the information.

Basic Trial Information

Phase

Type

Status

Age

Sponsor

Protocol IDs

No phase specified

Biomarker/Laboratory analysis

Unknown

Not specified

Other

SWWCI-MEDLUNGMEDLUNG, UKCRN-4682, EU-20862, NCT00899262

Objectives

To test and make a preliminary assessment of the sensitivity and specificity of Fourier transform infrared technology (FTIR) for use in the early detection of lung cancer in sputum samples from patients who have or participants at high risk for developing lung cancer and from non-high-risk smoking and non-smoking volunteers.

To permit identification of specific metabolic biomarkers within FTIR spectra that can distinguish between lung cancer, high-risk, and non-high-risk cases.

Entry Criteria

Disease Characteristics:

Meets 1 of the following criteria:

Diagnosis of lung cancer

At high risk for developing lung cancer

Non-high-risk smoking or non-smoking volunteer (control)

Prior/Concurrent Therapy:

Not specified

Patient Characteristics:

Not specified

Expected Enrollment

300

Outcomes

Primary Outcome(s)

Development of a cost-effective, high-throughput, and non-invasive screening test using Fourier transform infrared technology for detection of early lung cancer in sputum of high-risk people Discovery and characterization of novel metabolic biomarkers in sputum samples that permit detection of lung cancer at pre-cancerous and early lung cancer stages

Outline

This is a multicenter study.

Sputum samples and endobronchial biopsy tissue specimens are collected prior to routine bronchoscopy as part of a standard clinical assessment for the early detection of lung cancer. Sputum samples are examined for levels of bronchial and non-bronchial cells using established cytological and immunohistochemical procedures. Samples are also examined for metabolic biomarkers using Fourier transform infrared spectroscopy (FTIR) to generate complete metabolic fingerprints (i.e., spectra) that can distinguish metabolic differences between cancer, non-cancer, and early disease (i.e., dysplasia or metaplasia). These molecular biomarkers, which are detected within FTIR spectra, may be further analyzed in matched endobronchial biopsy tissue samples for histological confirmation. Additional clinico-pathological data is collected for each participant to allow development of predictive statistical models from the data.

Note: The purpose of some clinical studies is to help researchers learn more about how cancer cells grow and how drugs are used in the body. Cells and tissues collected from cancer patients may be used to detect new biomarkers that may be important in diagnosing and treating cancer in the future. The procedure or lab test described in this clinical study is intended to be carried out by clinical oncologists and researchers in carefully structured settings. Individual results obtained from these studies may not be made available to patients.